Zephyr Sleep Technologies Inc. (Zephyr), an innovation leader in bringing new products and technology to the field of dental sleep medicine, is announcing the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the MATRx plus™ a new class of medical device – the first ever “at-home” class II medical device to identify obstructive sleep apnea (OSA) patients suitable for oral appliance therapy.
MATRx plus™ is a multi-function device capable of performing both: i) a standard home sleep test (HST); and ii) an oral appliance trial. Ideally suited for a Dentist’s office, the MATRx plus™ will also be sold to sleep labs and clinics. The MATRx plus™’s unique and innovative tablet-based design is easy-to-use with instructional videos walking patients through the self-administered test in the comfort of their own home. Offering real-time, cloud connectivity, the MATRx plus™ simultaneously brings the patient’s study to the dentist’s office, the Sleep Physician’s office and Zephyr’s servers allowing for instant collaboration amongst health professionals and responsive customer support. The MATRx plus™ technology uses proprietary algorithms, AI and machine learning. The MATRx plus™ joins the already FDA cleared approved MATRx™ which is installed in over 200 sleep labs and clinics in the US.
Using an oral appliance to treat OSA is not new; however, in the past, dentists and sleep physicians have been plagued with high treatment failure rates (30-40%) and arduous titration protocols and guesswork to determine a treatment position. This is now all changed. The MATRx plus™ tells the medical professional IF a patient can be treated (reducing the failure rate) and HOW to treat by offering a therapeutic treatment position. The dentist uses this information to order and configure the oral appliance efficiently and effectively in a patient-friendly matter. “Never before has providing a sleep appliance been so easy” says Dr. Shouresh Charkhandeh, Zephyr’s Chief Dental Officer and renowned educator and researcher of dental sleep medicine.
Sleep-related breathing disorders, including OSA, affect as many as 25 percent of North American adults with most (over 85%) remaining undiagnosed and untreated. OSA has become arguably the most prevalent chronic non-communicable disease in industrialized society. In addition to a poor quality of life, OSA conveys an increased risk of cardiovascular disease, high blood pressure, type II diabetes and industrial and motor vehicle accidents. “Finally, we are able to confidently prescribe an alternative therapy to CPAP and invasive surgery to treat OSA” says Dr. John Remmers, Zephyr’s Chief Medical Officer. “Using a MATRx plus™ to responsibly and confidently select patients for oral appliances is the missing link to effectively treating a broader population”.
Zephyr has partnered with Dentsply Sirona, the world’s largest manufacturer of professional dental products and technologies, to bring MATRx plus™ to the United States market. “The FDA clearance for the MATRx plus is a significant achievement for Zephyr Sleep Technologies, our partner in developing the first 3D solution for obstructive sleep apnea therapy” says Walter Petersohn, Dentsply Sirona’s Chief Commercial Officer, “Details on how The Simple Sleep Solution will deliver better, safer and faster treatment will be announced at Dentsply Sirona World in September”.
“The FDA clearance of MATRx plus™ as a De Novo Class II medical device is a significant achievement for our company. The process involved three clinical studies, over 280 patients and rigourous testing on safety, effectiveness and usability. The MATRx plus™ is truly a new class of device that will change this industry” says Dr. Sabina Bruehlmann, Director Technology and Regulatory Affairs.
“Our team is very proud of this significant accomplishment which clearly puts Zephyr Sleep Technologies as the innovation, technology and now product leader in the dental sleep industry” says Paul Cataford, CEO. “We share this important milestone with our industry partners and look forward to bringing MATRx plus™ to every dental practice in the US”.
In Canada, Zephyr received Health Canada approval for MATRx plus™ in August 2016. The U.S launch of MATRx plus™ will be at the Dentsply Sirona World Conference (Orlando) on Thursday, September 13th, 2018.